Reduvir Hand Sanitizer by Culta S.A. de C.V.

Reduvir Hand Sanitizer by

Drug Labeling and Warnings

Reduvir Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Culta S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

REDUVIR HAND SANITIZER- ethyl alcohol solution 
Culta S.A. de C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient(s)

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic

Use

To decrease bacteria on the skin that could cause disease. Recommend for repeated use. For use when soap and water are not available.

Warnings

For external use only: hands.

Flammable. Keep away from heat and flame.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

For children under 6, use only under adult supervision. Not recommended for infants.

Other information

Do not store above150F. May discolor some fabrics.

Harmful to wood finishes and plastics.

Inactive ingredients

Water, Glycerin, Carbomer, Triethanolamine

Package Label - Principal Display Panel

500 mL NDC: 80358-002-05

1000 mL NDC: 80358-002-10

3785 mL NDC: 80358-002-37

REDUVIR HAND SANITIZER 
ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80358-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80358-002-05	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/31/2020
2	NDC: 80358-002-10	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/31/2020
3	NDC: 80358-002-37	3785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/31/2020	09/03/2020

Labeler - Culta S.A. de C.V. (951578576)

Establishment
Name	Address	ID/FEI	Business Operations
Culta S.A. de C.V.		951578576	manufacture(80358-002)

Revised: 9/2020

Document Id: ae6e596d-e037-9b31-e053-2a95a90a6efe

34390-5

Set id: ae34509b-46c9-5394-e053-2a95a90ad4cd

Version: 3

Effective Time: 20200903